A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques

Sponsor

Capital Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02305862

Collaborator

(none)

150

Enrollment

Location

Arms

53.9

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).

Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.

Condition or Disease	Intervention/Treatment	Phase
Arteriosclerosis Diabetes Mellitus Lipid Disorder	Drug: Rosuvastatin 5mg Drug: Rosuvastatin 20mg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low dose group (5mg) low dose Rosuvastatin	Drug: Rosuvastatin 5mg drug intervention
Experimental: high dose group (20mg) high dose Rosuvastatin	Drug: Rosuvastatin 20mg drug intervention

Arm

Intervention/Treatment

Experimental: low dose group (5mg)

low dose Rosuvastatin

Drug: Rosuvastatin 5mg

drug intervention

Experimental: high dose group (20mg)

high dose Rosuvastatin

Drug: Rosuvastatin 20mg

drug intervention

Outcome Measures

Primary Outcome Measures

To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI [26 weeks]

Secondary Outcome Measures

major adverse cardiovascular events [26 weeks]
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. [26 weeks]
To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks [26 weeks]
To evaluate the change from baseline in renal function (serum creatine) at 26 weeks [26 weeks]
To evaluate the change from baseline in creatine kinase at 26 weeks [26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction

Exclusion Criteria:

Planning coronary stenting
Heart failure
Uncontrolled hypertension（≥200/110mmHg)
Uncontrolled diabetes mellitus (HbA1C≥9.5%)
Hepatic insufficiency
Renal dysfunction
Cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing		China	100050

Sponsors and Collaborators

Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Buxing Chen, Director of department of cardiology, Capital Medical University

ClinicalTrials.gov Identifier:

NCT02305862

Other Study ID Numbers:

AMARIROCAP

First Posted:

Dec 3, 2014

Last Update Posted:

Jul 21, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Buxing Chen, Director of department of cardiology, Capital Medical University

Coronary Arteriosclerosis

Carotid Atherosclerotic Plaque

Rosuvastatin

Additional relevant MeSH terms:

Arteriosclerosis

Lipid Metabolism Disorders

Rosuvastatin Calcium

Study Results

No Results Posted as of Jul 21, 2016